Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-26 @ 5:04 AM
Study NCT ID:
NCT02827032
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2016-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlling and Lowering Blood Pressure With the MobiusHD™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Substudy Outcome Measure - Change in sympathetic activity', 'timeFrame': 'Baseline to 90 days post treatment', 'description': 'Change in muscle sympathetic nerve activity (burst frequency \\[bursts/min\\] and burst incidence \\[burst/100 heartbeats\\]) measured by microneurography, from baseline to 90 days post treatment'}, {'measure': 'Substudy Outcome Measure - Change in sympathetic activity', 'timeFrame': 'Baseline to 90 days post treatment', 'description': 'Change in Blood Oxygen Level Dependent (BOLD) activity of central sympathetic nerve circuits (connectivity of the salience network) measured by resting state BOLD fMRI'}, {'measure': 'Substudy Outcome Measure - Change in sympathetic activity', 'timeFrame': 'Baseline to 90 days post treatment', 'description': 'Change in Blood Oxygen Level Dependent (BOLD) activity of central sympathetic nerve circuits (brain(stem) response during the Valsalva maneuver) measured by task-based BOLD fMRI'}, {'measure': 'Substudy Outcome Measure - Change in baroreflex sensitivity', 'timeFrame': 'Baseline to 90 days post treatment', 'description': 'Change sympathetic baroreflex sensitivity (change in muscle sympathetic nerve activity per mmHg blood pressure change) during spontaneous blood pressure fluctuations'}, {'measure': 'Substudy Outcome Measure - Change in baroreflex sensitivity', 'timeFrame': 'Baseline to 90 days post treatment', 'description': 'Change in sympathetic baroreflex sensitivity (change in muscle sympathetic nerve activity per mmHg blood pressure change) during blood pressure changes evoked by the Valsalva maneuver'}, {'measure': 'Substudy Outcome Measure - Change in baroreflex sensitivity', 'timeFrame': 'Baseline to 90 days post treatment', 'description': 'Change in cardiac baroreflex sensitivity (change in heartbeat interval per mmHg blood pressure change) during spontaneous blood pressure fluctuations'}, {'measure': 'Substudy Outcome Measure - Change in baroreflex sensitivity', 'timeFrame': 'Baseline to 90 days post treatment', 'description': 'Change in cardiac baroreflex sensitivity (change in heartbeat interval per mmHg blood pressure change) during blood pressure changes evoked by the Valsalva maneuver'}], 'primaryOutcomes': [{'measure': 'Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)', 'timeFrame': 'Baseline to ninety (90) days post treatment', 'description': 'Change in the mean 24-hours systolic Ambulatory Blood Pressure'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'Baseline to three (3) years post treatment', 'description': 'Incidence of SAEs and UADEs reported from implantation through three years post treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hypertension'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '37555165', 'type': 'DERIVED', 'citation': 'Groenland EH, van Kleef MEAM, Hendrikse J, Spiering W, Siero JCW. The effect of endovascular baroreflex amplification on central sympathetic nerve circuits and cerebral blood flow in patients with resistant hypertension: A functional MRI study. Front Neuroimaging. 2022 Jul 25;1:924724. doi: 10.3389/fnimg.2022.924724. eCollection 2022.'}, {'pmid': '34784359', 'type': 'DERIVED', 'citation': 'van Kleef MEAM, Heusser K, Diedrich A, Oey PL, Tank J, Jordan J, Blankestijn PJ, Williams B, Spiering W. Endovascular baroreflex amplification and the effect on sympathetic nerve activity in patients with resistant hypertension: A proof-of-principle study. PLoS One. 2021 Nov 16;16(11):e0259826. doi: 10.1371/journal.pone.0259826. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.', 'detailedDescription': 'The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation.\n\nExclusion Criteria:\n\n* Known or clinically suspected baroreflex failure or autonomic neuropathy\n\nSubstudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair Medisch Centrum Utrecht)\n\nInclusion Criteria:\n\n\\- Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening\n\nExclusion Criteria:\n\n* Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be discontinued safely\n* Underlying conditions that prohibit microneurography, performance of a Valsalva maneuver and/or magnetic resonance imaging'}, 'identificationModule': {'nctId': 'NCT02827032', 'acronym': 'CALM-DIEM', 'briefTitle': 'Controlling and Lowering Blood Pressure With the MobiusHD™', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vascular Dynamics, Inc.'}, 'officialTitle': 'Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers', 'orgStudyIdInfo': {'id': 'CRD0328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MobiusHD™', 'description': 'The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.', 'interventionNames': ['Device: MobiusHD™']}], 'interventions': [{'name': 'MobiusHD™', 'type': 'DEVICE', 'description': 'The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.', 'armGroupLabels': ['MobiusHD™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Universitätsmedizin Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '60389', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sabine de Bruijn', 'role': 'CONTACT', 'email': 's.debruijn@cvcfrankfurt.de', 'phone': '+49 69 97947653'}, {'name': 'Horst Sievert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CVC Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '30451', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Uniklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Universitätsklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '12200', 'city': 'Berlin', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Charite Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Hamburg', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Asklepiod Klinik Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Homburg', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Universitatsklinikum des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '2545', 'city': 'The Hague', 'state': 'AA', 'status': 'COMPLETED', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '3435', 'city': 'Nieuwegein', 'state': 'EM', 'status': 'COMPLETED', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '6229', 'city': 'Maastricht', 'state': 'HX', 'status': 'COMPLETED', 'country': 'Netherlands', 'facility': 'Maastricht UMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6525GA', 'city': 'Nijmegen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3508 GA', 'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ingrid Klaassen', 'role': 'CONTACT', 'email': 'i.klaassen@umcutrecht.nl', 'phone': '+31 88 7559954'}, {'name': 'Corina Joosten', 'role': 'CONTACT', 'email': 'C.A.M.Joosten@umcutrecht.nl', 'phone': '+31 88 7559954'}, {'name': 'Wilko Spiering, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitair Medisch Centrum Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '8025AB', 'city': 'Zwolle', 'status': 'COMPLETED', 'country': 'Netherlands', 'facility': 'Isala', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'state': 'Scotland', 'status': 'WITHDRAWN', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth University Hospital - Glasgo', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'G81 4DY', 'city': 'Glasgow', 'state': 'Scotland', 'status': 'WITHDRAWN', 'country': 'United Kingdom', 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'status': 'WITHDRAWN', 'country': 'United Kingdom', 'facility': 'The Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'EC1A 7BE', 'city': 'London', 'status': 'COMPLETED', 'country': 'United Kingdom', 'facility': "St. Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'status': 'WITHDRAWN', 'country': 'United Kingdom', 'facility': "St. Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1E 6HX', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Donna Moskal-Fitzpatrick', 'role': 'CONTACT', 'email': 'donna.moskal@ucl.ac.uk', 'phone': '+44 207 679 9007', 'phoneExt': '09007'}, {'name': 'Bryan Williams', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joe Brookes', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9PL', 'city': 'Manchester', 'status': 'WITHDRAWN', 'country': 'United Kingdom', 'facility': 'Manchester University', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Lisa Green', 'role': 'CONTACT', 'email': 'lgreen@vasculardynamics.com', 'phone': '949.231.7602'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vascular Dynamics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}